College of Law > Academics > Centers, Institutes & Initiatives > Mary and Michael Jaharis Health Law Institute > e-Pulse Blog > FDA Zika Virus recommendations

The FDA Makes Recommendations Concerning the Zika Virus

The Zika virus has created concerns among professionals in the Health care industry, raising questions about the best way to tackle the recent public health emergency. Initially discovered in monkeys in 1947, the virus was first diagnosed in a human in Nigeria around 1954. Since then, the virus has slowly been spreading to areas in Africa, South East Asia, and the Pacific Islands. Although no locally transmitted cases have been reported in the United States, there have been cases reported amongst travelers returning from countries where the virus is spreading. In 2016, from January 3rd to March 5th, more than 4,500 people were tested for Zika, of which 182 tested positive.

The virus spreads primarily through infected mosquitos and produces minor symptoms; such as mild fevers, conjunctivitis, headaches, joint pains, and rashes. The main reason health authorities are concerned, however, is because of the virus’s confirmed link to  birth defects, namely microcephaly. Microcephaly is a defect in which a baby is born with a smaller than normal head, leading to improper brain development. The fact that Zika is a cause of microcephaly, can be sexually transmitted, and is found in individuals who have returned from areas where the virus is spreading, are all reasons why health authorities in the U.S. are taking safety measures to address the virus. One Such safety measure has been the FDA’s recommendation that Zika infected individuals be deferred from donating blood.

The FDA’s concern regarding blood transmission of Zika is premised on reports of transfusion associated infections that have occurred outside the U.S., specifically in Brazil, and the fact that many who are infected with Zika are not aware that they have symptoms. Zika symptoms typically do not last for more than a week and those affected typically do not visit the hospital because their condition does not worsen. The chances of someone contracting Zika and being aware are low, which could potentially affect the national blood supply if a Zika infected blood donor transmits his or her blood to another already ill patient. Therefore, the FDA is recommending that donors at risk of contracting the virus be deferred from donating blood for four weeks. Those at risk include anyone who has had Zika-related symptoms, sexual contact with someone who has traveled to or been in an area where the virus is spreading in the past three months, or traveled to areas that have a high transmission rate of Zika in the past four weeks.

In addition, the FDA recommends that blood collection centers update their donor history questionnaire to better determine which donors have a history of living in or visiting Zika-infected areas. The FDA also provides guidanc​e for those blood centers that have collected blood, distributed it, or know that it has been transfused. For blood centers that have collected blood from a donor that may be at risk of having Zika, the FDA recommends the center to quarantine and destroy all blood components collected. Likewise, for blood centers that have distributed blood already, the FDA recommends that the center advice the transfusion service to quarantine and destroy all blood components. Lastly, for blood centers that believe a transfusion has been made, the center should inform the blood transfusion recipient’s physician so that the physician can monitor the health of the patient. The FDA recommendations on blood transfusions are a source of guidance on how best to keep the nation’s blood supply healthy. Although the threat of a Zika virus outbreak in the U.S. is low, taking safety measures is necessary to remove any slight possibility of a public health crisis.

Faizan A. Khan is a second year law student at DePaul University College of Law. Mr. Khan graduated cum laude from DePaul University with a Bachelor of Arts in Political Science and minor In Economics. He is a fellow of The Jaharis Health Law Institute and will complete his J.D. in 2017.